A TIL-ing Odyssey Finally Ends in Approval for Iovance's AMTAGVI
Breaking down the approval of AMTAGVI and what it means for Iovance
Introduction
Iovance finally crossed the goal line with lifileucel. On Friday, February 16th, we got word that the company had won accelerated approval for AMTAGVI (lifileucel) for patients with advanced/metastatic melanoma who have been previously treated with a PD-1 inhibitor. Importantly, AMTAGVI becomes the first tumor-infiltrating lymphocyte (TIL) therapy and first cell therapy approved for solid tumors.
If you’ve followed this program or the company at all, you know it’s been a long road, with several hurdles, missteps, fumbles, and management changes, to get to this point. At one point, lifileucel was on track to be approved as early as the end of 2021 in melanoma AND cervical cancer, but regulatory concerns about its potency assay and trial design issues in cervical cancer delayed filing (multiple times) until May 2023.
Depending on which segment of the biotech world you speak to, you’ll get a different opinion about AMTAGVI. Some people think this drug is going to be a dud, others believe it’s a game-changer on a fast track to blockbuster status, and many are eager to know when Iovance will be acquired by a bigger fish looking to bolster its topline revenue. As someone who has been in the TIL space previously, I feel like I have great awareness of the benefits and challenges of TILs and good line of sight into the what the future of Iovance and AMTAGVI may hold.
Below, I do my best to tease apart the key issues, insights, and implications about this landmark approval and provide a realistic insider’s take on this important new therapy.
Some helpful links as you follow along: IOVA Feb 16th Corporate Presentation (1), AMTAGVI Package Insert (2).
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A meaningful advancement for patients and physicians
I said upfront that this approval was a long time coming for Iovance, but this was also the case for the many principal investigators, physicians, and “TIL evangelists” that the company has been working with to run their trials and get this drug approved over the last 5+ years. Many took to twitter/X to express their excitement about this approval. It even looks like the first surgical resection has already taken place, on Tuesday (Feb 20), at Stanford. It’s almost as if these key opinion leaders (KOLs) have been preparing for this approval for the last 3.5 years, given all the delays the AMTAGVI BLA has had leading up to this point.
Iovance and its KOL partners should be patting themselves on the back for staying the course to get AMTAGVI approved. Sure, the company shot itself in the foot a couple of times, but this is still an important milestone in the greater arc of cell therapy development, and more importantly, provides a necessary option to patients with post-PD-1 melanoma, who quite literally, had no effective options. When you see the outpouring of support and positivity from the KOL community about AMTAGVI, it’s a culmination of many years of hard work and an unrelenting desire to bring new treatments where none previously stood. Regardless of whether AMTAGVI turns out to be a blockbuster drug, it’s a meaningful development in the armamentarium against melanoma.